Trial Outcomes & Findings for Mechanisms of Lipodystrophy in HIV-Infected Pateints (NCT NCT00457665)
NCT ID: NCT00457665
Last Updated: 2019-07-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
12 and 24 months
Results posted on
2019-07-18
Participant Flow
Participant milestones
| Measure |
Nelfinavir
Randomized to receive Nelfinavir inclusive HAART
|
Efavirenz
Randomized to receive Efavirenz inclusive HAART
|
|---|---|---|
|
12 Months
STARTED
|
28
|
28
|
|
12 Months
COMPLETED
|
20
|
19
|
|
12 Months
NOT COMPLETED
|
8
|
9
|
|
24 Months
STARTED
|
20
|
19
|
|
24 Months
COMPLETED
|
15
|
11
|
|
24 Months
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Nelfinavir
Randomized to receive Nelfinavir inclusive HAART
|
Efavirenz
Randomized to receive Efavirenz inclusive HAART
|
|---|---|---|
|
12 Months
Drug allergy
|
1
|
1
|
|
12 Months
High HIV viral load
|
5
|
1
|
|
12 Months
Lipodystrophy
|
2
|
0
|
|
12 Months
Withdrawal by Subject
|
0
|
2
|
|
12 Months
Abnormal Liver function tests
|
0
|
5
|
|
24 Months
Withdrawal by Subject
|
3
|
2
|
|
24 Months
Lipodystrophy
|
1
|
1
|
|
24 Months
Abnormal liver function tests
|
1
|
5
|
Baseline Characteristics
Data for 2 patients were not available
Baseline characteristics by cohort
| Measure |
Nelfinavir
n=28 Participants
Randomized to receive Nelfinavir inclusive HAART
|
Efavirenz
n=28 Participants
Randomized to receive Efavirenz inclusive HAART
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
56 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=28 Participants
|
4 Participants
n=28 Participants
|
9 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=28 Participants
|
24 Participants
n=28 Participants
|
47 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=28 Participants
|
5 Participants
n=28 Participants
|
10 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=28 Participants
|
19 Participants
n=28 Participants
|
33 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=28 Participants
|
4 Participants
n=28 Participants
|
13 Participants
n=56 Participants
|
|
Weight
|
75.4 kgs
STANDARD_DEVIATION 11 • n=28 Participants
|
75 kgs
STANDARD_DEVIATION 13.8 • n=28 Participants
|
75.18 kgs
STANDARD_DEVIATION 12.3 • n=56 Participants
|
|
Body Mass Index
|
25.2 kg/m2
STANDARD_DEVIATION 3.8 • n=28 Participants
|
24.8 kg/m2
STANDARD_DEVIATION 5 • n=28 Participants
|
24.9 kg/m2
STANDARD_DEVIATION 4.3 • n=56 Participants
|
|
CD4 count
|
312 per cubic mm
STANDARD_DEVIATION 210 • n=28 Participants • Data for 2 patients were not available
|
301 per cubic mm
STANDARD_DEVIATION 158 • n=26 Participants • Data for 2 patients were not available
|
307 per cubic mm
STANDARD_DEVIATION 185 • n=54 Participants • Data for 2 patients were not available
|
|
HIV Viral load
|
82000 copies per mL
n=28 Participants • Values for 3 participants were not available
|
103000 copies per mL
n=25 Participants • Values for 3 participants were not available
|
97900 copies per mL
n=53 Participants • Values for 3 participants were not available
|
|
Fasting plasma glucose
|
92.5 mg/dL
STANDARD_DEVIATION 9.0 • n=26 Participants • Values of 3 participants were not available
|
90.3 mg/dL
STANDARD_DEVIATION 5.6 • n=27 Participants • Values of 3 participants were not available
|
91.4 mg/dL
STANDARD_DEVIATION 7.4 • n=53 Participants • Values of 3 participants were not available
|
|
Triglycerides
|
129 mg/dL
STANDARD_DEVIATION 83.8 • n=28 Participants
|
133.5 mg/dL
STANDARD_DEVIATION 81.4 • n=28 Participants
|
131.24 mg/dL
STANDARD_DEVIATION 82 • n=56 Participants
|
PRIMARY outcome
Timeframe: 12 and 24 monthsPopulation: Some subjects dropped before 1 year and some dropped between 1-2 years.
Outcome measures
| Measure |
Nelfinavir (Viracept)
n=20 Participants
Assigned to Nelfinavir
|
Efavirenz (Sustiva)
n=20 Participants
Assigned to Efavirenz
|
|---|---|---|
|
Effect of Drug Regimens on Serum Triglycerides.
At 12 months
|
228.0 mg/dL
Standard Deviation 119.0
|
230.4 mg/dL
Standard Deviation 157.3
|
|
Effect of Drug Regimens on Serum Triglycerides.
At 24 months
|
293.4 mg/dL
Standard Deviation 350.6
|
290.0 mg/dL
Standard Deviation 276.1
|
Adverse Events
Nelfinavir
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Efavirenz
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nelfinavir
n=28 participants at risk
These participants were randomized to receive Nelfinavir
|
Efavirenz
n=28 participants at risk
These participants were randomized to receive Efavirenz
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
3.6%
1/28 • Number of events 1 • 24 months
|
0.00%
0/28 • 24 months
|
|
Gastrointestinal disorders
Vomiting and diarrhea
|
0.00%
0/28 • 24 months
|
3.6%
1/28 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Spider bite
|
0.00%
0/28 • 24 months
|
3.6%
1/28 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Nelfinavir
n=28 participants at risk
These participants were randomized to receive Nelfinavir
|
Efavirenz
n=28 participants at risk
These participants were randomized to receive Efavirenz
|
|---|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
21.4%
6/28 • Number of events 6 • 24 months
|
35.7%
10/28 • Number of events 10 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
46.4%
13/28 • 24 months
|
3.6%
1/28 • 24 months
|
|
Hepatobiliary disorders
Abnormal liver function tests
|
3.6%
1/28 • Number of events 1 • 24 months
|
35.7%
10/28 • Number of events 10 • 24 months
|
|
Psychiatric disorders
Disturbing dreams
|
7.1%
2/28 • 24 months
|
32.1%
9/28 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
3.6%
1/28 • Number of events 1 • 24 months
|
17.9%
5/28 • Number of events 5 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place